Actively Recruiting
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2026-01-16
170
Participants Needed
1
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
No predictive factors are known for the response to the bevacizumab anti-angiogenic molecule (Avastin) given in the event of relapse of glioblastoma (GBM) following radiochemotherapy. Classical MRI with gadolinium injection and perfusion is not sufficient to predict survival and response or duration. We propose to evaluate the prognostic interest for 6-month survival of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism recorded at 7 and 28 days of application of the treatment. These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients
CONDITIONS
Official Title
Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 88 years with histologically confirmed glioblastoma in first relapse after surgery, temozolomide, and radiotherapy
- Polymorphonuclear neutrophils count greater than 1500 / mm3
- Platelet count greater than 100,000 / mm3
- SGOT-SGPT levels less than 5 times the upper limit of normal
- Bilirubin level less than 1.5 times the upper limit of normal
- Creatinine less than 1.5 times the normal serum level and adequate creatinine clearance
- Proteinuria less than 1 gram per 24 hours
- Patient has health insurance
- Signed consent by the patient if lucid, or by a trusted person if not
You will not qualify if you...
- Symptomatic cerebral or tumor hemorrhage
- Karnofsky Index less than 50%
- Prior treatment with antiangiogenic molecules or Gliadel for diagnosis or recurrence
- Coagulation disorders affecting injectable treatments like bevacizumab
- Contraindications to MRI such as pacemakers, intraocular foreign bodies, or electrodes
- Severe uncontrolled illnesses, including other active cancers except treated skin tumors or in situ cervical or breast cancer
- Uncontrolled infection
- Uncontrolled hypertension with systolic blood pressure over 160 mm Hg despite treatment
- Coronary artery disease, unstable arterial disease, or evolving aneurysm
- Myocardial infarction within the last 6 months
- Peripheral arterial or cerebrovascular accident within the last 6 months
- Heart failure greater than grade II NYHA
- Hemorrhagic diseases such as hemophilia or Willebrandt
- Nephrotic syndrome with proteinuria over 2 grams per 24 hours
- Hemoptysis within the last month
- Pulmonary embolism within the last month
- Major surgery within the last month except craniotomy or stereotactic biopsy
- History of digestive fistula or intestinal perforation resolved less than 6 months ago
- Hypersensitivity to bevacizumab or its components
- Hypersensitivity to Chinese hamster ovary cells or other humanized antibodies
- Severe myelosuppression
- Pregnancy or nursing; contraception required during treatment
- Persons deprived of liberty or under legal guardianship
- Participation in another clinical trial with an ongoing exclusion period
- Refusal to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
J
Jean-Marc CONSTANS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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